510(k) · Cleared
ClearedPhantom® Hindfoot TTC/TC Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 17, 2020 as substantially equivalent to K192163 (Paragon 28, Inc., 2020) and 1 other predicate after a 72-day review. Its family tree reaches back 16 generations to 1996. 5 later devices descend from it.
- Decided
- Jul 17, 2020
- Review
- 72 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K954385 (1996). 292 ancestors in all, the oldest K791619 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
- 2 generations backK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- 1 generation backK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- This deviceK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK251850 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253591 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241262 Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 14 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 13 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 12 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 11 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 10 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 9 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 8 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 7 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 6 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 3 generations backK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
- 2 generations backK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- 1 generation backK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- This deviceK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · cites it directly2descendants
- K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025 · cites it directly1descendant
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · 2 generations on1descendant
- K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2026 · 2 generations on0descendants
- K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −15 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −14 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −13 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −12 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −11 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −10 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −9 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −8 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −7 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −6 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −3 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
| −2 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| −1 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| 0 (this device) | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +1 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
| +1 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | — |
| +2 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +2 | K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026 | — |
| +3 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 15 | 0 |
| 1997 | 7 | 0 |
| 1998 | 10 | 0 |
| 1999 | 11 | 0 |
| 2000 | 19 | 0 |
| 2001 | 28 | 0 |
| 2002 | 25 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 21 | 0 |
| 2006 | 15 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 11 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192163 | TTC Phantom® Intramedullary Nail SystemSummary page 4…II Product Code: HSB, HWC Common Name: Intramedullary Nail Predicate Device: TTC Phantom® Intramedullary Nail System (Primary: K192163, Additional: K191782) Indications for Use: The Phantom® Hindfoot TTC/TC Nail System is intended for… | 2020 |
| * | K191782 | TTC Phantom Intramedullary Nail SystemSummary page 4…SB, HWC Common Name: Intramedullary Nail Predicate Device: TTC Phantom® Intramedullary Nail System (Primary: K192163, Additional: K191782) Indications for Use: The Phantom® Hindfoot TTC/TC Nail System is intended for tibiotalocalcaneal arthr… | 2019 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 74 of the 292 ancestors have a recall of any class.
- Of its descendants, K210869 (Paragon 28, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: * Post-traumatic or degenerative arthritis * Previously infected arthrosis * Revision of failed ankle arthrodesis * Revision of failed total ankle arthroplasty » Talar deficiency…
Read the full statement (134 words)
The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
* Post-traumatic or degenerative arthritis
* Previously infected arthrosis
* Revision of failed ankle arthrodesis
* Revision of failed total ankle arthroplasty
» Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
* Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
» Rheumatoid arthritis
* Osteoarthritis
* Nonunions or pseudarthrosis of hindfoot and distal tibia
* Trauma (severe or malunited tibial pilon fracture)
* Charcot foot (neuroarthropathy)
» Severe end-stage degenerative arthritis
» Instability and skeletal defects after tumor resection
» Pantalar arthrodesis
» Severe foot/ankle deformity
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201227 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201227: Phantom® Hindfoot TTC/TC Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201227
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026